Understanding user requirements to improve adoption of influenza diagnostics in clinical care within Metro Manila

Gerth‐Guyette, Emily; Malacad, Carol C.; Demonteverde, Ma Paz; Faulx, Dunia; Lochhead, Michael J.; Lupisan, Socorro; Leader, Brandon T.; Tallo, Veronica

doi:10.1002/hsr2.75

Cited by 3 publications

(4 citation statements)

References 24 publications

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“…Depending on the target or disease program, intended users of RDTs in LRS may be clinical healthcare workers and trained lay providers (such as in the case of malaria and cholera) (29). Alternatively, some RDTs-although conceived for POC testing outside the laboratory-are mainly used within (basic) laboratories and with laboratory technicians as the user-an example RDTs used for influenza diagnosis (79). Given the surveillance component of the COVID-19 response, this may be the case for part of the COVID-19 RDTs, too.…”

Section: Usability and Robustnessmentioning

confidence: 99%

“…Robustness (sturdiness) of the RDT is measured in so-called flex studies which study the RDT performance while mimicking procedural (user) errors (such as adding too few or too much sample volume) and harsh environmental conditions for storage (humidity, light, temperature). Usability and flex studies identify and mitigate potential user-related hazards, orient training and supervision needs, improve workflow and ergonomics, and promote integration of the IVD in the healthcare system (79).…”

Section: Usability and Robustnessmentioning

confidence: 99%

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Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

et al. 2020

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Introduction: For the COVID-19 (SARS-CoV-2) response, COVID-19 antigen (Ag), and antibody (Ab) rapid diagnostic tests (RDTs) are expected to complement central molecular testing particularly in low-resource settings. The present review assesses requirements for implementation of COVID-19 RDTs in sub-Saharan Africa. Methods:Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products.Results: In total 47 articles on two COVID-19 Ag RDTs and 54 COVID-19 Ab RDTs and IFUs of 20 COVID-19 Ab RDTs were retrieved. Only five COVID-19 Ab RDTs (9.3%) were assessed with capillary blood sampling at the point-of-care; none of the studies were conducted in sub-Saharan Africa. Sampling: Challenges for COVID-19 Ag RDTs include nasopharyngeal sampling (technique, biosafety) and sample stability; for COVID-19 Ab RDTs equivalence of whole blood vs. plasma/serum needs further validation (assessed for only eight (14.8%) products). Sensitivity-Specificity: sensitivity of COVID-19 Ag and Ab RDTs depend on viral load (antigen) and timeframe (antibody), respectively; COVID-19 Ab tests have lower sensitivity compared to laboratory test platforms and the kinetics of IgM and IgG are very similar. Reported specificity was high but has not yet been assessed against tropical pathogens. Kit configuration: For COVID-19 Ag RDTs, flocked swabs should be added to the kit; for COVID-19 Ab RDTs, finger prick sampling materials, transfer devices, and controls should be added (currently only supplied in 15, 5, and 1/20 products). Usability and Robustness: some COVID-19 Ab RDTs showed high proportions of faint lines (>40%) or invalid results (>20%). Shortcomings were reported for buffer vials (spills, air bubbles) and their instructions for use. Stability: storage temperature was ≤30 • C for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. Integration in the healthcare setting requires a target product profile, landscape overview of technologies, certified manufacturing capacity, a sustainable market, and a stringent but timely regulation. In-country deployment depends on integration in the national laboratory network. Jacobs et al. COVID-19 Rapid Tests in Sub-Saharan Africa Discussion/Conclusion: Despite these limitations, successful implementation models in triage, contact tracing, and surveillance have been proposed, in particular for COVID-19 Ab RDTs. Valuable experience is available from implementation of other disease-specific RDTs in sub-Saharan Africa.

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Section: Usability and Robustnessmentioning

confidence: 99%

Section: Usability and Robustnessmentioning

confidence: 99%

Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

et al. 2020

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“…Furthermore, we assessed robustness and ease of use. Robustness testing of in vitro diagnostics is encouraged to anticipate end users’ challenges, particularly in LRS [ 35 , 36 ]. To our knowledge, other commercial phenotypic identification systems have not yet been tested for robustness.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of MicroScan Bacterial Identification Panels for Low-Resource Settings

et al. 2021

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Bacterial identification is challenging in low-resource settings (LRS). We evaluated the MicroScan identification panels (Beckman Coulter, Brea, CA, USA) as part of Médecins Sans Frontières’ Mini-lab Project. The MicroScan Dried Overnight Positive ID Type 3 (PID3) panels for Gram-positive organisms and Dried Overnight Negative ID Type 2 (NID2) panels for Gram-negative organisms were assessed with 367 clinical isolates from LRS. Robustness was studied by inoculating Gram-negative species on the Gram-positive panel and vice versa. The ease of use of the panels and readability of the instructions for use (IFU) were evaluated. Of species represented in the MicroScan database, 94.6% (185/195) of Gram-negative and 85.9% (110/128) of Gram-positive isolates were correctly identified up to species level. Of species not represented in the database (e.g., Streptococcus suis and Bacillus spp.)), 53.1% out of 49 isolates were incorrectly identified as non-related bacterial species. Testing of Gram-positive isolates on Gram-negative panels and vice versa (n = 144) resulted in incorrect identifications for 38.2% of tested isolates. The readability level of the IFU was considered too high for LRS. Inoculation of the panels was favorably evaluated, whereas the visual reading of the panels was considered error-prone. In conclusion, the accuracy of the MicroScan identification panels was excellent for Gram-negative species and good for Gram-positive species. Improvements in stability, robustness, and ease of use have been identified to assure adaptation to LRS constraints.

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“…By accurately detecting low-intensity infections, a new test may not only help to improve decision-making related to use of MDA but also contribute toward the eventual elimination of STH infections. PATH’s integrated product development process includes an early consideration for user and customer needs, as well as implementation constraints and market dynamics [14]. (Fig 1) Planning for sustainable access throughout the product lifecycle is imperative to achieving public health impact [15].…”

Section: Introductionmentioning

confidence: 99%

Formative research to inform development of a new diagnostic for soil-transmitted helminths: Going beyond the laboratory to ensure access to a needed product

et al. 2019

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Soil-transmitted helminths (STHs) affect more than 1.5 billion people. The global strategy to control STH infections requires periodic mass drug administration (MDA) based on prevalence among populations at risk determined by diagnostic testing. Widely used copromicroscopy methods to detect infection, however, have low sensitivity as the prevalence and intensity of STH infections decline with repeated MDA. More sensitive diagnostic tools are needed to inform program decision-making. Using an integrated product development process, PATH conducted qualitative and quantitative formative research to inform the design and development of a more sensitive test for STH infections. The research, grounded in a conceptual framework for ensuring access to health products, involved stakeholder analysis, key opinion leader interviews, observational site visits of ongoing STH surveillance programs, and market research including market sizing, costing and willingness-to-pay analyses. Stakeholder analysis identified key groups and proposed strategic engagement of stakeholders during product development. Interviews highlighted features, motivations and concerns that are important for guiding design and implementation of new STH diagnostics. Process mapping outlined current STH surveillance workflows in Kenya and the Philippines. Market sizing in 2016 was estimated around half a million tests for lower STH burden countries, and 1–2 million tests for higher STH burden countries. The cost of commodities per patient for a molecular STH diagnostic may be around $10, 3–4 times higher than copromicroscopy methods, though savings may be possible in time and staffing requirements. The market is highly price sensitive as even at $5 per test, only 27% of respondents thought the test would be used by surveillance programs. A largely subsidized STH control strategy and a semi-functional Kato-Katz test may have created few incentives for manufacturers to innovate in STH diagnostics. Diverse partnerships, as well as balancing needs and expectations for new STH diagnostics are necessary to ensure access to needed products.

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Understanding user requirements to improve adoption of influenza diagnostics in clinical care within Metro Manila

Cited by 3 publications

References 24 publications

Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review

Evaluation of MicroScan Bacterial Identification Panels for Low-Resource Settings

Formative research to inform development of a new diagnostic for soil-transmitted helminths: Going beyond the laboratory to ensure access to a needed product

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